Secondary Pharmaceutical Patents: A Global Perspective · Secondary Pharmaceutical Patents: A...
Transcript of Secondary Pharmaceutical Patents: A Global Perspective · Secondary Pharmaceutical Patents: A...
Secondary Pharmaceutical Patents: A Global Perspective
Kenneth C. Shadlen (LSE)
[Bhaven N. Sampat (Columbia)]
WHO-WIPO-WTO Trilateral Symposium Panel 3
26 February 2018
Primary vs. Secondary Patents
Compounds Alternative structural forms; formulations, compositions, dosages, combinations; uses • Not processes
Primary Patents are applied for earlier and are usually stronger legally
Why File for Secondary Patents?
Sequential accumulation of patents on alternative dimensions of existing molecules and drugs can extend periods of market exclusivity.
Love it or Hate it
Responding to the Challenges of Secondary Patents
Litigation Examination
Responding to the Challenges via Examination: National Responses
India • Allows product patents in 2005 • Section 3(d) • Explicit: No secondary patent unless enhanced efficacy
Brazil • Allows product (and process) patents in 1997 • Dual examination system, INPI and ANVISA (2012 change) • De facto restriction on secondary patents
Argentina • Allows product patents in 2000 • Revisions to examination guidelines • Second uses not patentable (2001-- ); highly restrictive (2012 --)
National Policies in the Spotlight
India, Brazil, and Argentina • Different designs; functional equivalents • Grant pharma patents, as per WTO/TRIPS, but curb secondary Intelligent Compliance or Mock Compliance? • “Counter-hegemonic” approach to meeting obligations • Violating spirit – if not letter – of TRIPS
– Especially IN/BR, less attention to AR
Heat vs. Light… • What do measures to curb secondary patents achieve? Research!
1. International applications (PCT) that may be filed nationally – 2000-2002; filings in EU/JP/US; Jan-July – N=5,193
2. Code primary vs. secondary – Coding guide; expert consultant; coding individual claims but
classification at patent level (any “primary” claim = “primary”) – Primary 38%, Secondary 62%
3. Identify national applications and outcomes in 6 “countries” – 3 with systems to address secondary patents (IN, BR, AR) – 3 developed (EU, Japan, US)
4. Brazil, India, Argentina: Detailed outcomes, prosecution histories, fieldwork
Data
Grant Rates by Country
overall
“twins”
Detailed Outcomes for Secondary Applications
Backlog as Filter? Backlog as de facto “Deferred Examination” System?
Possible Indirect Effects
On Filing
• Deterrent?
– but these applications filed before systems fully in place
On Granting
• India: Changes how examiners approach applications, in general (new world view)?
• Brazil: INPI examiners act differently because of ANVISA (second set of eyes)?
• Argentina: Codification of pre-existing practices?
Conclusions
Restrictions on secondary patents per se having minimal direct effects on secondary patenting outcomes • Secondary grant rates (relative to primary) not less in
countries with restrictions than without restrictions • Argentina different, but even there a small part
Why so much attention to 3(d) and Prior Consent? • Possibilities of emulation (fear/hope) • Appreciation and abhorrence of deviation from norm • Symbolism: not what they do but what they mean • Indirect effects
Thank you
Ken Shadlen
Bhaven N. Sampat and Kenneth C. Shadlen, “Secondary pharmaceutical patenting: A global perspective,” Research Policy, Vol. 46, No. 3 (April 2017), pp. 693-707.
Extra slides
Grant rates for secondary applications by family size
Grant rates for secondary applications by US status